Informações:
Falhas:
ID
16663
Descrição
Tolerability of Rebif® Injection With and Without the Use of Rebiject™Mini in Relapsing-Remitting Multiple Sclerosis Subjects; ODM derived from: https://clinicaltrials.gov/show/NCT00292253
Link
https://clinicaltrials.gov/show/NCT00292253
Palavras-chave
Versões (1)
- 30/07/2016 30/07/2016 -
Transferido a
30 de julho de 2016
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Multiple Sclerosis, Relapsing-remitting NCT00292253
Eligibility Multiple Sclerosis, Relapsing-remitting NCT00292253
- StudyEvent: Eligibility
Similar models
Eligibility Multiple Sclerosis, Relapsing-remitting NCT00292253
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
age
Item
greater than or equal to 18 years of age
boolean
C0001779 (UMLS CUI [1])
relapsing-remitting ms
Item
has relapsing-remitting ms
boolean
C0751967 (UMLS CUI [1])
study compliance
Item
are willing and able to comply with the protocol for the duration of the study
boolean
C1321605 (UMLS CUI [1])
leukopenia/lymphopenia
Item
has significant leukopenia/lymphopenia (white blood cell count less than (<) 0.5 times the lower limit of normal)
boolean
C0023530 (UMLS CUI [1,1])
C0023508 (UMLS CUI [1,2])
C0024312 (UMLS CUI [2])
C0023508 (UMLS CUI [1,2])
C0024312 (UMLS CUI [2])
has elevated liver function tests
Item
has elevated liver function tests (aspartate aminotransferase [ast], alanine transaminase [alt], or alkaline phosphatase greater than (>) 2 times the upper limit of normal or total bilirubin > 1.5 times the upper limit of normal)
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C1561546 (UMLS CUI [3])
C0201913 (UMLS CUI [4])
C0201836 (UMLS CUI [2])
C1561546 (UMLS CUI [3])
C0201913 (UMLS CUI [4])
has an allergy to human serum albumin or mannitol
Item
has an allergy to human serum albumin or mannitol
boolean
C0020517 (UMLS CUI [1,1])
C0071512 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0024730 (UMLS CUI [2,2])
C0071512 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0024730 (UMLS CUI [2,2])
had treatment with an investigational product or procedure within 3 months
Item
had treatment with an investigational product or procedure within 3 months
boolean
C1514463 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,2])
systemic disease interfering with study protocol compliance
Item
has the presence of systemic disease or abnormal laboratory findings that might interfere with subject safety, compliance or evaluation of the condition under study
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
concomitant medication
Item
has concomitant use of avonex®, betaseron®, copaxone®, or novantrone®
boolean
C2347852 (UMLS CUI [1,1])
C0594372 (UMLS CUI [1,2])
C2347852 (UMLS CUI [2,1])
C0284968 (UMLS CUI [2,2])
C2347852 (UMLS CUI [3,1])
C0282248 (UMLS CUI [3,2])
C0594372 (UMLS CUI [1,2])
C2347852 (UMLS CUI [2,1])
C0284968 (UMLS CUI [2,2])
C2347852 (UMLS CUI [3,1])
C0282248 (UMLS CUI [3,2])